Kornimate/medical-research-clean huggingface dataset:
polyacrylamide hydrogel injection treatment for anal incontinence

Conditions: Anal Incontinence

Summary: a randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide hydrogel injection therapy for anal incontinence.

a prospective randomized study to assess the use of bulkamid for anal incontinence using three different transanal injection techniques . patients with anal incontinence severity wexner score \>7. standardised injection treatment at baseline. clinical status and subjective symptom evaluation (wexner score and fiql) at baseline, 2 months, 6 months and 1 year.

Eligibility criteria:
inclusion criteria: * informed consent, anal incontinence with wexner score \>10 exclusion criteria: * ino additional pregnancies, schedule for pelvic organ surgery within 1 year of treatment, current or previous pelvic organ cancer, insulin treated diabetes, inflammatory bowel disease
primary care, communication, and improving children's health

Conditions: Childhood Obesity; Overweight; Communication; Weight Loss

Summary: the purpose of this study is to determine communication content and strategies in primary care that predict improvement in weight status among overweight school-age children.

we will test whether 1) pediatrician-patient communication regarding overweight status, behavior/risk-factor counseling, and the frequency and time to next follow-up visit, compared with either no communication or incomplete communication (communicating only high weight status without behavior/risk-factor counseling or a follow-up visit) will predict improvement in weight status at one year follow-up, and 2) during pediatrician-patient communication regarding weight and weight management, higher patient-centeredness will predict improvement in weight status at one year follow-up. the communication content identified will generate new information about the most effective content and style of pediatrician-patient communication that predict weight-status improvement. because we prospectively will examine clinical practice elements in the one-year interval between well-child visits, acknowledging that communication regarding high weight status may initiate assessment of risk factors for heart disease (such as high cholesterol and blood sugar), more frequent follow-up visits, or prompt a nutrition referral, we will generate novel information about the most effective clinical practices and follow-up interval and frequency that predict weight-status improvement in overweight children. we also will examine if the content and style of communication are related to improvements in diet and lifestyle behaviors at one-year follow-up.

Eligibility criteria:
inclusion criteria: * schedule a well-child visit with a participating pediatrician * agree to return in one year for the follow-up well-child visit * overweight * 6-12 years old * have a working telephone and/or e-mail address * child/parent willing to provide assent/consent exclusion criteria: * unstable illness (such as uncontrolled asthma) * developmental condition (such as trisomy 21) * planning to move/leave practice within two years

Keywords: childhood obesity overweight communication primary care weight management communication methods patient-centered communication
study of tysabri in early relapsing remitting multiple sclerosis participants

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the purpose of this study is to evaluate the impact of an early treatment with natalizumab on the management of the progressive nature of relapsing remitting multiple sclerosis (rrms).


Eligibility criteria:
key inclusion criteria: * documented diagnosis of relapsing remitting multiple sclerosis (mcdonald 2010 criteria). * edss ≤ 3.0. * must fulfill tysabri indication (relapse and mri criteria). * decision to start treatment with natalizumab must precede enrollment. * up to four natalizumab infusions. key exclusion criteria: * any prior treatment with natalizumab. * prior imunossupressive treatment (mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab). * contraindications to treatment with natalizumab. * history of progressive multifocal leukoencephalopathy (pml) or other opportunistic infections, or an increased risk for such infections. * immunocompromised at the time of enrollment. known active malignancies. * inability to comply with study requirements. note: other protocol defined inclusion/exclusion criteria may apply.
incentives for adherence in adolescent asthma

Conditions: Asthma; Asthma in Children

Summary: financial incentives have been suggested as a possible means for increasing adherence to asthma medications. this study will evaluate an incentive strategy (daily small reward for adherence) in maintaining high levels of adherence as tracked by adherence sensors in adolescents with asthma.

two groups will be enrolled. the control group will have mediation monitoring sensors placed on their controller inhalers. the treatment group will also have the monitoring sensors placed on their medications, however they will be paid up to $1 per day for perfect adherence for 3 months. both groups will be monitored for 4 months. 10 subjects will be chosen from each group to complete semi-structured phone interviews

Eligibility criteria:
inclusion criteria: * physician diagnosed asthma * on at least one inhaled controller medication exclusion criteria: * language other than english or spanish (these are the only languages supported by the adherence monitoring application) * other severe chronic lung disease including tracheostomy/ventilator dependence, interstitial lung disease or cystic fibrosis, or significant developmental delay.

Keywords: adherence incentives
back to basics: addressing childhood obesity through traditional foods in alaska

Conditions: Obesity

Summary: back to basics is a mixed-methods intervention trial to reduce the prevalence of obese alaska native children by increasing the proportion of nutrient-dense traditional and non-traditional foods consumed, and decreasing consumption of sugar-sweetened beverages (ssbs). this 5-year intervention trial targeting 0-5 year olds is conducted in partnership with rural community action program, inc. (rcap) head start (hs), early head start (ehs), and parents as teachers (pat) programs in 12 rural alaskan communities in the yukon-kuskokwim (yk) region, where each site is assigned to either a 9-month nutritional education and meal program intervention or a standard education and meal program repeating annually. this intervention trial aims to increase consumption of local traditional foods and nutrient-dense non-traditional foods, decrease ssb consumption, and decrease prevalence of obesity in children 3-5 years old by: (1) adjusting the nutritional content of existing meal services provided by rcap to children ages 3-5 years; (2) providing culturally relevant nutrition education to families of children 0-5 years; (3) developing local and community driven initiatives that provide knowledge and skills and engage families in the gathering and preparing of local traditional foods; and (4) incorporating available and emerging resources (e.g. fish/farm-to- schools) to increase integration of traditional foods into the diet. phase 1 involves the collection and analysis of formative and baseline data to help guide the intervention in phase 2. phase 1 includes: 1. gathering baseline height/weight and food/ssb consumption data previously collected on children ages 0-5 years enrolled in yk rcap programs. 2. conducting formative studies in the 12 yk communities to better understand attitudes towards childhood obesity and barriers/enablers to traditional foods consumption 3. creating/integrating a traditional foods-focused nutrition curriculum into rcap menu programs in yk communities. 5. work to expand the "fish to schools" and "farm to preschool" programs into yk rcap hs programs. phase 2 includes implementing: 1. a physical activity curriculum in hs programs in all communities 2. a traditional food in hs menu program in intervention communities 3. a home-based nutrition program in intervention communities 4. a mechanism to document traditional foods important to each community


Eligibility criteria:
inclusion criteria: * for the focus group discussions: consenting alaska native residents of the 12 communities involved in the study, aged 18 and over. * for the intervention study: upon parental or guardian consent, alaska native residents of the 12 communities involved in the study, aged 0-5 years and enrolled in the rural cap head start, early head start, or parents as teachers, programs exclusion criteria: * none
a study evaluating the effectiveness and safety of risdiplam administered in pediatric patients with spinal muscular atrophy who experienced a plateau or decline in function after gene therapy

Conditions: Muscular Atrophy, Spinal

Summary: this is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered in pediatric participants with sma and 2 smn2 copies who previously received onasemnogene abeparvovec and experience a plateau or decline in function. participants to be enrolled are children \<2 years of age genetically diagnosed with sma.


Eligibility criteria:
inclusion criteria: * \<2 years of age at the time of informed consent * confirmed diagnosis of 5q-autosomal recessive sma * confirmed presence of two smn2 gene copies * administration of onasemnogene abeparvovec pre-symptomatically or post-symptomatically * has received onasemnogene abeparvovec for sma no less than 3 months prior to enrollment * in the opinion of the investigator, has demonstrated a plateau or decline in function post-gene therapy (with a duration of 6 months or less) documented by 2 individual time points in the functions as follows: swallowing and one additional function/ability (respiratory, motor function, other) per appropriate expectation. exclusion criteria: * treatment with investigational therapy prior to initiation of study treatment * any unresolved standard-of-care laboratory abnormalities per the onasemnogene abeparvovec prescribing information * concomitant or previous administration of a smn2-targeting antisense oligonucleotide or smn2 splicing modifier either in a clinical study or as part of medical care * requiring invasive ventilation or tracheostomy * presence of feeding tube and an orsat score of 0 * hospitalization for pulmonary event within the last 2 months, or any planned hospitalization at the time of screening * any major illness requiring hospitalization within 1 month before the screening examination or any febrile illness within 1 week prior to screening and up to first dose administration.
efficacy confirmation trial of cdp870 as add-on medication to methotrexate (mtx) in japanese rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: the objective of this trial is to investigate the efficacy (american college of rheumatology 20% : acr20) superiority of two dose regiments of cdp870 versus placebo in combination with mtx in active ra patients who have an incomplete response to mtx. the pharmacokinetics and immunogenicity profile of cdp870 will also be investigated to assess the extrapolability of foreign data to the japanese population.


Eligibility criteria:
inclusion criteria: * subjects must have a diagnosis of adult-onset ra of at least 6 months but not longer than 15 years in duration as defined by the 1987 american college of rheumatology classification criteria. * subjects must have active ra disease as defined by: * at least 9 tender joints and 9 swollen joints * esr of 30 mm/hour or crp of 1.5 mg/dl * subjects must have received treatment with mtx for at least 6 months prior to the start of study drug administration. the dose of mtx must have remain fixed for at least 2 months prior to the study and the dose of mtx should be within 6 to 8 mg/week. exclusion criteria: * patients who have a diagnosis of any other inflammatory arthritis * patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia) * patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy) * patients who have nyha (new york heart association) class iii or iv congestive heart failure * patients who currently have, or who have a history of, tuberculosis * patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease) * patients who currently have, or who have a history of, malignancy * female patients who are breastfeeding or pregnant, who are of childbearing potential * patients who previously received treatment with 2 or more anti-tnfα drugs or who previously failed to respond to treatment with 1 or more aint-tnfα drugs.

Keywords: rheumatoid arthritis certolizumab pegol cimzia
the effect of continuous pulse oximetry monitoring and early intervention using wearable device on the incidence of postoperative hypoxemia

Conditions: Postoperative Respiratory Complication

Summary: vital signs of postoperative patient are monitored intensively in post-anesthesia care unit or intensive care unit, but the frequency of surveillance decreases in typical surgical wards. the continuous pulse oximetry in surgical wards is known to be useful in detection and prevention of hypoxemia, reducing complications caused by postoperative respiratory depression. however, continuous monitoring is not conducted, due to shortage of equipment and personnel. recently, wearable device for measuring pulse oxygen saturation, which is inexpensive, applicable to patients with mobility, and can be monitored continuously through wireless connection, has been supplied. in this study, the investigators evaluate the effect of continuous monitoring of oxygen saturation with wireless device(masimo radius-7) on postoperative patients who are transferred to general wards, and evaluate the effect of early intervention in reducing the event of hypoxemia.


Eligibility criteria:
inclusion criteria: * patients undergoing noncardiac surgery under general anesthesia * american society of anesthesiologists (asa) physical status class i-iii exclusion criteria: * patients refusing to participate in the study * patients under emergency surgery * patients who wearable device is not applicable * patients scheduled to be transferred to intensive care unit * patients scheduled to receive oxygen supplementation in surgical ward * patients scheduled to undergo continuous pulse oximetry monitoring
tgrx-678 phase i oral pharmacokinetic study

Conditions: Chronic Myeloid Leukemia

Summary: a study evaluating the effects of food intake on the pharmacokinetic (pk) profiles of tgrx-678

this study is designed as single-center, single-dose, randomized, open-label and parallel-comparison to evaluate food effect on pk profile of tgrx-678 in healthy subjects. safety and tolerability of the drug is also evaluated during study.

Eligibility criteria:
inclusion criteria: * healthy participants, male or female * age between 18 and 45 (both inclusive) * body weight: male ≥ 50 kg, female ≥ 45 kg; body mass index (bmi) between 19.0 and 26.0 kg/m\^2 (both inclusive) * signing informed concent at own will * able to communicate with researcher and able to complete study per protocol instruction exclusion criteria: * clinically significant abnormal results in lab test, physical exam or 12-lead electrocardiogram (ecg) test * positive results for hepatitis b, hepatitis c, hiv or syphilis * qt interval elongation as indicated by 12-lead ecg test during screening period * use of any medication that could impact cyp3a4 enzyme activities within 30 days prior to screening period * use of any medication within 14 days of first dose of the investigational drug * vaccinated within 30 days of first dose of the investigational drug, or planning to be vaccinated during study * history of instrumental cardiovascular diseases * received major surgery within 6 months prior to screening, or with surgical wounds not completely healed * history of any severe disease or conditions that could affect study results per investigator's discretion * history of allergic conditions or is allergic to components of the investigational drug * having conditions that could affect drug absorption or difficulties to swallow * history of smoking of \>5 cigarettes per day within 3 months prior to screening, or cannot stop tabacco using during study * history of alcohol abuse, or alcohol consumption of \>14 unit alcohol within 3 months prior to screening * history of substance use, or tested positive for drug test during screening * history of specific food (i.e., grapefruit, mango) consumption, or/and large tea/coffee/caffeinated drink/grapefruit product intake of \> 8 cups per day, within 2 weeks prior to first dose * having special dietary requirement and cannot comply with food requirement of the study * pregnant or breastfeeding female, or tested positive in pregnancy test * history of unprotected sexual activities within 1 month prior to screening * having plans for pregnancy during the study and within 6 months after study completion; or not agreeing to take strict contraceptive measures during study and within 6 months after study completion * history of blood loss/ blood donation of ≥ 400 ml within 3 months prior to screening, or planning to donate blood within 1 month after study completion * any reasons that is deemed unsuitable for study participation as determined by investigator
clinical evaluation of modified 2.2mm microincision phacoemulsification for age-related cataract

Conditions: Cataract

Summary: this study is a single-center, parallel-group, randomized controlled trial with the following objectives: to compare the incidence of post-operative descemet membrane detachment (dmd) in phacoemulsification surgery between modified and conventional 2.2mm microincision.

2.2mm incision is considered an ideal incision size in phacoemulsification. however, dmd is a common and serious complication in 2.2mm microincision phacoemulsification for hard nucleus age-related cataract. dmd is originated from the incision in the operation. how to construct the appropriate incision shape and size for reducing the occurrence of dmd is an important problem to be solved urgently in phacoemulsification surgery. the investigators found that enlarging the internal incision could increase the range of motion of surgical instruments and reduce the friction of instruments to incision. therefore，the incidence of dmd would be reduced. the investigators developed this technique, modified 2.2mm incision, to reduce the incidence of incision-site dmd and not to increase other incision related complications. in this trial, the investigators aim to compare modified and conventional 2.2mm incision with regard to safety and efficacy in reducing the incidence of dmd.

Eligibility criteria:
inclusion criteria: * aged-related cataract patients between 65 and 90 years ; * lens nuclear opalescence grade ≥4.0 on the lens opacities classification system iii (locs iii); * scheduled for phacoemulsification combined with intraocular lens implantation. * the number of corneal endothelial cells \> 1500cells/mm2. * dilated pupil diameter ≥6mm exclusion criteria: * a history of ophthalmic trauma or surgery; * other ophthalmic diseases such as glaucoma, uveitis, high myopia; * ocular factors that would make surgery challenging or dangerous, including but not limited to small pupil, shallow anterior chamber, etc.
integrated genetic and functional analysis of the influence of menstrual hygiene products on female health

Conditions: Vaginal Disease; Menstrual Discomfort

Summary: women's reproductive health has attracted increasing attention in recent years, including in the field of microbiology. vaginal infections, such as vulvovaginal candidiasis, bacterial vaginosis and aerobic vaginitis, are common and a huge burden on our society. the vaginal microbiome is important in the prevention of these infections, in fertility and for healthy pregnancies. the composition, and therefore the 'health' of the vaginal microbiome, is influenced by many internal and external factors, including intimate health. however, it is not yet known how intimate health, and specifically the use of menstrual hygiene products, affects the microbiome and women's intimate comfort and health. in this study, the researchers aim to understand the influence of 5 menstrual hygiene products (tampon, menstrual cup, menstrual pad and 2 types of menstrual underwear) on women's intimate health (n = 100). first, this will be evaluated at the microbiome level, focusing on the female intimate microbiome, consisting of the skin in the groin, vulvar and vaginal microbiome. these sites are all closely linked and are affected in vaginal infections or by contact with menstrual hygiene products. second, in addition to the direct impact on the microbiome, the impact on the participant's immune system will be evaluated, as some well-known menstrual hygiene products can cause irritation and inflammation. as a third goal, participants will assess the comfort and usability of each menstrual hygiene product and provide data on their lifestyle and other factors that may influence our results. the main goal is to investigate and define the impact of menstrual hygiene products on women's intimate health so that women can make an informed choice. in a first phase participants (n = 1500) will fill in a survey containing questions on general health, lifestyle and menstrual health. based on these responses a selection of 100 participants will be made by the researchers to participate in the intervention trial.


Eligibility criteria:
inclusion criteria: * female * contraception: combination pill with stop week or no hormonal contraception * premenopausal * dutch-speaking living in belgium * regular menstrual cycle (if no hormonal contraception) exclusion criteria: * pregnancy

Keywords: menstrual health intimate health